Ulcerative ColitisNCT00805428
Importance of CD4+CD25+ly in UC1. Investigation of Difference Between Blood Concentration IL 17, IL 33, Regulatory T ly in Patients With UC and Control Group
An observational study of Ulcerative Colitis, run by Clinical Hospital Center, Split at 1 site in Croatia.
Trial summary
Mucosal inflammation in patients with UC is the result of immunosuppression disturbance because decreasing number of regulatory T ly and activation IL 17 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 32 participants
- Where
- 1 siteCroatia
- Study dates
- Sep 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patients with UC and control group
Who may be able to join
- endoscopic confirmed diagnosis
Who cannot join
- corticosteroid or immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Klinički bolnički centar Split
Split
Jasna Ajdukovic, MSc, 0917983374, jasna.ajdukovic@gmail.com
About this study
Mucosal inflammation in patients with UC is the result of immunosuppression disturbance because decreasing number of regulatory T ly and activation IL 17
- Conditions
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2 | control group | |
| patients with UC | patients with UC, without corticosteroid or immunosuppressive therapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Center, Split
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805428
- Sponsor's protocol ID
- UC
- Status last verified
- Dec 2008
- First submitted
- 8 Dec 2008
- Last updated
- 9 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of CD4+CD25+ly in UC1. Investigation of Difference Between Blood Concentration IL 17, IL 33, Regulatory T ly in Patients With UC and Control Group
- ClinicalTrials.gov ID
- NCT00805428
- Acronym / sponsor ID
- UC
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Clinical Hospital Center, SplitUniversity, hospital or other
- Study start
- Sep 2008
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mucosal inflammation in patients with UC is the result of immunosuppression disturbance because decreasing number of regulatory T ly and activation IL 17
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | – | –control group |
| patients with UC | – | –patients with UC, without corticosteroid or immunosuppressive therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients with UC and control group
Key inclusion criteria (1 listed)
- endoscopic confirmed diagnosis
Key exclusion criteria (1 listed)
- corticosteroid or immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Clinical Hospital Center, Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasna Ajdukovic, MSc (0917983374, jasna.ajdukovic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2008.